The Safety and Immunogenicity Study of Rotavirus Vaccine Simultaneously Vaccinated With MR or MMR Vaccine

Phase 4

• Conditions: Rotavirus
• Interventions: Biological: rotavirus vaccine; Biological: measles-rubella vaccine; Biological: measles-mumps-rubella vaccine

• Registration Number: NCT02153866
• Lead Sponsor: Sichuan Center for Disease Control and Prevention

Brief Summary

Nowadays these are some vaccines being vaccinated simultaneously, and a doubt is aroused if the safety and immunogenicity are same between inoculating several vaccines simultaneously and inoculating individually. So we carry out this study.

The purpose of this study is to evaluate the difference of safety and immunogenicity on vaccinating rotavirus vaccine simultaneously with measles-rubella vaccine(MR) or measles-mumps-rubella vaccine(MMR) compared to vaccinating rotavirus vaccine, MR or MMR individually.

Detailed Description

1. Quality control plan:

1. All vaccinators should get professional training held by local Health Bureau, and be qualified by local Health Bureau.

2. All the clinical trial related staffs are trained by provincial or prefectural Center for Disease Control and prevention (CDC) at the beginning.

3. Provincial and prefectural CDCs conduct supervision at each step, especially during field vaccination and Adverse Events Following Immunization (AEFI) investigation.

4. Data valid check is designed to work in the database inputting, double entry and validation is also required.

5. The field works are conduct under SOP (Standard Operating Procedures), The SOP for vaccination procedures which include vaccinee recruitment and vaccination practice etc. is 'Immunization Work Specification' issued by China Ministry of Health in 2005. The SOP for AEFI surveillance is 'AEFI surveillance guideline' issued by China Ministry of Health in 2010.

2. Statistical plan

1. Safety evaluation The analytic data include all reactions or events within 30 days after vaccination, compare the incidence of reactions among different vaccines, the statistical method is chi-square.

2. Immunogenicity evaluation Compare the antibody positive rate and Geometric Mean Concentration between pre-vaccination and post-vaccination, and among different vaccine combinations.

3. safety evaluation method

At the time of vaccination, vaccinees were instructed to report any adverse event to physicians or vaccination providers. Adverse events that were fatal or that resulted in disability and clusters of events (i.e., notably high numbers of similar adverse events related to a certain vaccine) were required to be reported within 2 hours after their occurrence. The following adverse events were required to be reported within 2 days after their occurrence: anaphylaxis or other allergic reactions occurring within 24 hours after vaccination; fever (axillary temperature, \>38.5°C), angioedema, or a local injection-site reaction (diameter, \>2.5 cm) occurring within 5 days after vaccination; purpura, an Arthus reaction, febrile convulsion, seizure, or polyneuritis occurring within 15 days after vaccination. Other reactions that were common and minor (e.g., mild pain and fatigue) were not required to be reported.

4. Immunogenicity evaluation

Enzyme-linked immunosorbent assay (abbreviated as ELSIA) is used to quantitatively test immunoglobulin G (IgG) of measles, rubella, mumps, test kit is provided by Virion\\Serion company. Rotavirus Immunoglobulin A (RV-IgA) is used to test the antibody of rotavirus.

Study Timeline

• Study Start: 2013-12
• Status Verified: 2014-05
• Primary Completion: 2014-05
• Study First Submitted: 2014-05-26
• Study First Submitted QC: 2014-06-02
• Last Update Submitted: 2014-06-02
• Study First Posted: 2014-06-03
• Last Update Posted: 2014-06-03
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2800

Inclusion Criteria

• Aged 8~9 months healthy child
• Subjects or guardians who can and will comply with the requirements of the protocol
• Without vaccination history of rotavirus vaccine, measles-rubella vaccine and measles-mumps-rubella vaccine.
• Axillary temperature is under 37.0℃.
• Accord with the requirement of drug manual of rotavirus vaccine,measles-rubella vaccine and measles-mumps-rubella vaccine.

Exclusion Criteria

• Allergic to any component of the vaccines.
• Women of pregnancy, lactation or about to be pregnant in 60 days.
• Infected by some rash disease within one month.
• Known severe immunodeficiency (e.g., from hematologic and solid tumors, receipt of chemotherapy, congenital immunodeficiency, or long-term immunosuppressive therapy or patients with HIV infection who are severely immunocompromised).
• Any prior administration of immunoglobulins, any other vaccines or experimental drugs in the last 4 weeks.
• Family history of seizures or progressive neurological disease.
• Diarrheal caused by rotavirus or lasting for 3 or more days.
• Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
rotavirus	rotavirus vaccine	vaccinate one dose rotavirus vaccine for each of 700 participants aged 8\~9months
measles-rubella	measles-rubella vaccine	vaccinate one dose measles-rubella vaccine for each of 350 participants aged 8\~9 months.
measles-mumps-rubella	measles-mumps-rubella vaccine	vaccinate one dose measles-mumps-rubella vaccine for each of 350 participants aged 8\~9 months.
rotavirus, measles-mumps-rubella	rotavirus vaccine	simultaneously vaccinate one dose rotavirus vaccine and one dose measles-mumps-rubella vaccine for each of 700 participants aged 8\~9 months.
rotavirus, measles-rubella	rotavirus vaccine	simultaneously vaccinate one dose rotavirus vaccine and one dose measles-rubella vaccine for each of 700 participants aged 8\~9 months.
rotavirus, measles-rubella	measles-rubella vaccine	simultaneously vaccinate one dose rotavirus vaccine and one dose measles-rubella vaccine for each of 700 participants aged 8\~9 months.
rotavirus, measles-mumps-rubella	measles-mumps-rubella vaccine	simultaneously vaccinate one dose rotavirus vaccine and one dose measles-mumps-rubella vaccine for each of 700 participants aged 8\~9 months.

Primary Outcome Measures

Name	Time	Method
the occurrence rate of general reaction of different vaccination groups	1 months after vaccination	general reaction includes fever (axillary temperature\> 3.85℃), local injection-site reaction (diameter\> 2.5 cm) etc.

Secondary Outcome Measures

Name	Time	Method
The variation of antibody Geometric Mean Titer compared between before and after vaccination	1 month after vaccination	this measure is used to assess the immunogenicity of different groups
the occurrence rate of severe adverse event of different vaccination groups	1 month after vaccination	severe reaction include: anaphylaxis, angioedema, purpura, an Arthus reaction, febrile convulsion, seizure, polyneuritis, other adverse events cause fatal, result in disability or clusters of events (i.e., notably high numbers of similar adverse events related to a certain vaccine)